Job Description
Scismic is supporting the continued growth of one of the largest healthcare manufacturing organizations in the world.
They are seeking a Senior Scientist - Microbiology (Quality) to join the team in Portsmouth, New Hampshire.
About the job
Act as a senior team member of the Quality Control department to support technology transfer, validation, deviation support, and investigation projects. Subject Matter Expert for more than one discipline. Technical writer of test methods, protocols, and reports as well as contributor to Annual Product Reviews and other Regulatory documents. Direct contact with customers and project teams. Acts as advisor to junior staff to meet schedules and/or resolve technical problems. Provides guidance to junior staff to achieve goals in accordance with established policies. Troubleshoot assay and instrumentation issues involving data mining, trending, and analysis to identify problems.
Key Responsibilities
1. Direct all technical transfer projects within their area of responsibility ensuring on-time completion.
2. Write/review transfers, validations, deviations, investigations, and facility support. Perform assay work and guide others for transfers, validations, deviations, investigations, and facility support.
3. Represent QC and the company in customer meetings to receive/deliver information, requests, and requirements. Resolve technical and business decisions as required.
4. Ensure success of method post-technical transfer to include training of personnel for execution and review, reviewing of data, and completion of documentation.
5. Create metrics to measure throughput, performance, and other appropriate KPIs and report them to management. Identify, drive, and influence others towards completion of department goals. Remove roadblocks for team members to complete their goals.
6. Develop the technical, GMP, and leadership skills of QC personnel through efficiencies and hands-on training opportunities. Act as mentor to junior staff within the entire QC organization.
7. If the position has direct reports: complete performance reviews of subordinate QC personnel. Hold routine 1:1 meetings with staff. Responsible for planning and assigning work, hiring, pay increases, performance management, and disciplinary issues as required. Ensure direct report on-time completion of work.
Perform other duties as assigned.
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